Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused by the COVID-19 pandemic. Salamol MDIs are marketed by IVAX Pharmaceuticals in the UK; Teva acquired IVAX in 2006. Health Canada recently … [Read more...] about Teva Canada imports supply of UK-branded salbutamol (albuterol) MDIs under interim order
Medical
VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval by the FDA. The company said that it submitted the proposal through the FDA's Coronavirus Treatment Acceleration Program (CTAP). PH94B … [Read more...] about VistaGen proposes Phase 2a study of PH94B nasal spray for the treatment of anxiety related to the COVID-19 pandemic
Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
Verona Pharma says that the FDA's comments in response to the data from a Phase 2 study of the company's RPL554 nebulized ensifentrine for the treatment of COPD support moving ahead with a Phase 3 clinical program. The Phase 3 program, called ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy), is planned for later this year. In January 2020, Verona … [Read more...] about Verona moving ahead with planning for Phase 3 study of nebulized ensifentrine after receipt of FDA comments
Senzer to develop inhaled antivirals for the treatment of COVID-19
Senzer Pharmaceuticals has announced the launch of a new Critical Care Division for development of two inhaled anti-viral drugs for the treatment of COVID-19. The company did not specify which drugs it planned to develop but did say that the formulations would be delivered via MDI rather than with its SIDD (Systemic Inhaled Delivery Device), which is used for its … [Read more...] about Senzer to develop inhaled antivirals for the treatment of COVID-19
Phase 3 trial of Oyster Point’s OC-01 varenicline nasal spray for dry eye meets primary endpoint
Oyster Point Pharma has announced that the Phase 3 ONSET-2 trial of the company's OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear film production as measured by Schirmer's score for more patients using OC-01 than for patients using a control. A number of secondary endpoints were … [Read more...] about Phase 3 trial of Oyster Point’s OC-01 varenicline nasal spray for dry eye meets primary endpoint
iCAIR consortium initiates project to develop inhaled drugs for COVID-19
A consortium called Fraunhofer International Consortium for Anti-Infective Research (iCAIR) -- composed of researchers from Fraunhofer ITEM, Griffith University, Hannover Medical School, and Twincore -- has announced that it has initiated a project to develop inhaled drugs to treat COVID-19, starting with high-throughput screening for candidates by temporary … [Read more...] about iCAIR consortium initiates project to develop inhaled drugs for COVID-19
Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
Pulmotect said that it plans to initiate two Phase 2 trials of its PUL-042 immunostimulant inhalation solution for the prevention and treatment of COVID-19 within a week after getting the go-ahead from the FDA. In January 2020, the company announced that preclinical studies of PUL-042, which is made up of Toll-like receptor agonists, demonstrated that it could protect … [Read more...] about Pulmotect gets FDA okay for two Phase 2 trials of PUL-042 for the prevention and treatment of COVID-19
FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19
The FDA has approved an IND for a Phase 2 study of GeneOne Life Science's GLS-1200 nasal spray for the prevention of COVID-19, the company said. According to GeneOne, GLS-1200 stimulates nasal production of nitric oxide, which has been shown to inhibit coronavirus activity. The study of GLS-1200 for prevention of COVID-19 is expected to enroll 225 healthcare … [Read more...] about FDA approves IND for Phase 2 study of GeneOne Life Science nasal spray for the prevention of COVID-19
AAAAI publishes new data showing bioequivalence of ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray to injected epinephrine
The American Academy of Allergy, Asthma & Immunology (AAAAI) has published results of three Phase 1 studies of ARS Pharmaceuticals' ARS-1 (Neffy) intranasal epinephrine that had been scheduled for presentation at the AAAAI annual meeting. The FDA granted Fast Track designation to the ARS-1 for the treatment of anaphylaxis in February 2019. The studies, EPI … [Read more...] about AAAAI publishes new data showing bioequivalence of ARS Pharmaceuticals’ ARS-1 epinephrine nasal spray to injected epinephrine
Alnylam and Vir select candidate for development as inhaled COVID-19 vaccine
Alnylam Pharmaceuticals and Vir Biotechnology have announced that they intend to meet with the FDA soon regarding an IND for VIR-2703 (ALN-COV), an inhaled siRNA in development for prevention and/or treatment of COVID-19. The companies said that VIR-2703 may also have activity against other coronaviruses. The collaboration agreement between Vir and Alnylam includes … [Read more...] about Alnylam and Vir select candidate for development as inhaled COVID-19 vaccine